Attachment 3 - Waiver Request Letter

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Date:	February 05, 2009
To:	Julie A. Wise, Policy Analyst (OMB) Via Mikia Currie (NIH)
From:	Susan Yurgalevitch
Subject:	Request for waiver using the OMB Race/Ethnicity Standards for “The Prevalence and Incidence of HIV Molecular Variants and Their Correlation with Risk Behaviors and HIV Treatment in Brazilian Blood Donors (NHLBI): 200810-0925-006.” This study is designed to examine HIV risk behaviors and the incidence and prevalence of HIV among blood donors. The study’s prospective surveillance and case-control design will enable the potential enrollment of all eligible HIV seropositives detected at the four participating blood centers in Brazil. A comparison of epidemiological risk profiles will be made between the seropositive donors and randomly selected seronegative donors. We are requesting a waiver from using the standard OMB race/ethnicity for the above project to use the basic race/ethnic categories of the Brazilian Institute of Geography and Statistics (IBGE). The OMB categories were developed to more accurately reflect the diverse U.S. population and not necessarily the population of other countries. We would like to use these categories since these are the standard categories for reporting race in Brazil. These categories represent the broad population groups that reside in Brazil and will be recognizable by the blood donors since this is what is used for their census. Using the OMB standards may be confusing to the donor and may lead to mis-classification of the study population. Thank you for your consideration.